Life Sciences

Life Sciences

Yes, you read that correctly. There are significant changes coming to the FDA’s electronic Drug Registration and Listing System (eDRLS) that require action from most drug labelers before the end of the year. You may have heard that, as part of the eDRL Final Rule...

If your organization markets medical devices in the United Kingdom, you may have heard about the National Health Service (NHS) eProcurement program. Sometimes loosely referred to as the “U.K. UDI,” eProcurement shares some traits with FDA’s UDI program, but is quite...

As you probably know by now, FDA recently announced it would extend the Class I UDI compliance date for labeling and GUDID submissions by two years to September 24, 2020. In this post, we will take a look at why FDA chose to take this step and how Class I labelers...

Did you know that Health Canada, the department of the Canadian government that regulates drug products, is engaged in a pilot program to introduce electronic submissions of drug product information in Structured Product Labeling (SPL) format? Officially named the...

On June 7 and 8, the medical device industry joined the FDA for the ninth Annual UDI Conference. With a recent UDI extension for Class I device labelers, industry members had an increased interest in FDA’s commentary on the state of the UDI mandate. During the two-day...

Every product on the market in the U.S. containing an active drug ingredient is required to be electronically drug listed with the FDA and assigned a National Drug Code (NDC). During this process, drug labelers submit complete electronic copies of the Content of...

As you probably know by now, FDA’s deadline for Unique Device Identification (UDI) depends on device class. Class III device labelers had until September 2014 to comply, followed by Implantable, Life-Supporting, Life-Sustaining devices in 2015 and Class II devices in...

The Reed Tech Life Sciences Team is pleased to announce that we are now offering a full-service solution to allow medical device organizations to share product data with trading partners through the Global Data Synchronization Network (GDSN). This will allow device...

In our last post, we discussed how the media, Congress and the FDA is paying increased attention in recent years to medical device safety. We highlighted the cost to the device industry of FDA enforcement actions (Reed Tech estimates $4 billion per year). We also...

If you regularly watch TV news, visit online news sites or listen to news radio, you have probably seen a lot of medical devices in the mainstream media in recent years. Unfortunately, much of this attention has been negative, centered on adverse events resulting in...

Did you know that FDA recently updated some technical documents related to GUDID submissions? On March 31, the agency sent an email to its list of GUDID email subscribers with links to an updated GUDID Data Elements Reference Table and GUDID HL7 SPL Implementation...

Each company responsible for submitting drug product listings will have its own unique schedule for submission to FDA based on application approval dates and updates to labeling and listing information. However, FDA has established several specific reporting periods...

GDUFA, or the Generic Drug User Fee Amendments, were passed by Congress in 2012, with the purpose of “speed[ing] access to safe and effective generic drugs to the public and reduc[ing] costs to industry.” Among other things, the initiative authorized FDA to collect...

HORSHAM, PA – February 8, 2017 – Reed Tech, a provider of data management solutions for the life sciences industry, and 1WorldSync, the world’s largest global content exchange network, have entered into a collaborative agreement to enable more robust...

If your company manufactures drug products for distribution in the United States, you probably know that you are required to register your establishment site(s) annually with FDA in Structured Product Labeling (SPL) format. Many manufacturers are unaware, however,...

One of the topics our team receives frequent questions about is National Drug Codes (NDCs). How are they structured? Where do they come from? What’s the difference between an NDC labeler code, product code and package code? To help industry members understand...